FDA Certificates Sample Clauses

FDA Certificates. The Foundation will undertake all actions and file all documentation reasonably necessary to obtain approval(s) for each Licensed Products/Services from the U.S. Food and Drug Administration ("FDA") or similar agencies for all countries in which the Parties may mutually decide to Market the Licensed Products/Services, as may be required under applicable law. The Foundation will provide Palmera with copies of all documentation related to such approval and keep apprised of the progress and outcome of such approvals(s). In the event that the Foundation is unable or unwilling to perform such obligation or otherwise obtain such approval(s) for each Licensed Product/Services, Palmera shall have the right, but not the obligation, to file for such approvals for each Licensed Product/Services or otherwise assume the approval in progress by the Foundation. Each resulting approval at the time of issuance shall be deemed to be a part of the FDA Certificates and licensed to Palmera under the License for purposes of this Agreement. The selection of the countries in which approvals will be pursued shall be determined by mutual agreement by the Parties on a case by case basis based upon the relative cost and benefit of pursuing such approvals pursuant to the Protocol.
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Related to FDA Certificates

  • FIRPTA Certificates Prior to the purchase of Shares pursuant to Section 3 hereof, Stockholder shall provide to Parent, Purchaser or the Paying Agent (as defined in the Merger Agreement), as the case may be, a certificate of non-foreign status as provided in Treasury Regulation Section 1.1445-2(b) (the "FIRPTA Certificate"). If a Stockholder fails to deliver the FIRPTA Certificate, Parent, Purchaser or the Paying Agent, as the case may be, shall be entitled to withhold the amount required to be withheld pursuant to Section 1445 of the Code from amounts otherwise payable to Stockholder pursuant to the Merger Agreement or this Agreement.

  • Tax Certificates Each Lender that is organized under the laws of any jurisdiction other than the United States shall deliver to the Administrative Agent for transmission to the Borrower, on or prior to the Effective Date (in the case of each Lender listed on the signature pages hereof) or on the effective date of the Assignment and Acceptance Agreement pursuant to which it becomes a Lender (in the case of each other Lender), and at such other times as may be necessary in the determination of the Borrower or the Administrative Agent (each in the reasonable exercise of its discretion), including upon the occurrence of any event requiring a change in the most recent counterpart of any form set forth below previously delivered by such Lender to the Borrower, such certificates, documents or other evidence, properly completed and duly executed by such Lender (including Internal Revenue Service Form 1001, Form 4224, Form W-8 or Form W-9, or any successor form, or any other certificate or statement of exemption required by Treasury Regulations Section 1.1441-4(a) or Section 1.1441-6(c) or any successor thereto) to establish that such Lender is not subject to deduction or withholding of United States federal income tax under Section 1441 or 1442 of the Code or otherwise (or under any comparable provisions of any successor statute) with respect to any payments to such Lender of principal, interest, fees or other amounts payable under any of the Loan Documents. The Borrower shall not be required to pay any additional amount to any such Lender under Section 2.10(b)(iii) if such Lender shall have failed to satisfy the requirements of the immediately preceding sentence; provided that if such Lender shall have satisfied such requirements on the Effective Date (in the case of each Lender listed on the signature pages hereof) or on the effective date of the Assignment and Acceptance Agreement pursuant to which it becomes a Lender (in the case of each other Lender), nothing in this Section shall relieve the Borrower of its obligation to pay any additional amounts pursuant to Section 2.10(b)(iii) in the event that, as a result of any change in applicable law, such Lender is no longer properly entitled to deliver certificates, documents or other evidence at a subsequent date establishing the fact that such Lender is not subject to withholding as described in the immediately preceding sentence.

  • Class PO Certificates Private Certificates..................................... Class P, Class B-4, Class B-5 and Class B-6 Certificates. Rating Agencies.......................................... Fitch and S&P. Regular Certificates..................................... All Classes of Certificates other than the Class A-R Certificates. Residual Certificate..................................... Class A-R Certificates.

  • Senior Certificates Class 1-A-1, Class 1-A-2, Class 1-A-3, Class 1-A-4, Class 1-A-5, Class 1-A-6, Class 1-A-7, Class 1-A-8, Class 1-A-9, Class 1-A-10, Class 1-A-11, Class 1-A-12, Class 1-A-13, Class 1-A-14, Class 1-A-15, Class 1-A-16, Class 1-A-17, Class 1-A-18, Class 1-A-19, Class 1-A-20, Class 1-A-21, Class 1-A-22, Class 1-A-R, Class 1-A-MR and Class 1-A-LR Certificates.

  • Closing Certificates The Administrative Agent shall have received a certificate of the Credit Parties, dated the Original Closing Date, substantially in the form of Exhibit I to the Original Credit Agreement, with appropriate insertions, executed by the President or any Vice President and the Secretary or any Assistant Secretary of each Credit Party, and attaching the documents referred to in Section 6.7.

  • Form of the Certificates (a) The Certificates shall be substantially in the form of Exhibit A. The Certificates shall represent the entire beneficial interest in the Trust. The Certificates shall be executed on behalf of the Trust by manual or facsimile signature of a Responsible Officer of the Owner Trustee. Certificates bearing the manual or facsimile signatures of individuals who were, at the time when such signatures shall have been affixed, authorized to sign on behalf of the Trust, shall be duly issued, fully paid and non-assessable beneficial interests in the Trust, notwithstanding that such individuals or any of them shall have ceased to be so authorized prior to the authentication and delivery of such Certificates or did not hold such offices at the date of authentication and delivery of such Certificates. (b) The Certificates shall be typewritten, printed, lithographed or engraved or produced by any combination of these methods (with or without steel engraved borders) all as determined by the officers executing such Certificates, as evidenced by their execution of such Certificates. The Certificates shall be fully registered. (c) The Certificates shall be issued in fully-registered form. The terms of the Certificates set forth in Exhibit A shall form part of this Agreement.

  • Certificates Principal Life hereby agrees to deliver an Officer’s Certificate, a copy of which is attached hereto as Exhibit E, on a quarterly basis to any rating agency currently rating the Program. The Trust hereby agrees to deliver an Officer’s Certificate, a copy of which is attached hereto as Exhibit F, on a quarterly basis to any rating agency currently rating the Program.

  • LIBOR Certificates Notional Amount Certificates........... None. Notional Amount Components............. None. Offered Certificates................... All Classes of Certificates other than the Private Certificates. Physical Certificates.................. Class A-R Certificates and the Private Certificates. Planned Principal Classes.............. None.

  • Other Certificates Any other certificates of approval, acceptance or compliance required by Lender from any Governmental Authority having jurisdiction over the Mortgaged Property and the Repairs.

  • Temporary Certificates (a) Pending the preparation of definitive Certificates, upon the order of the Depositor, the Trustee shall execute and shall authenticate and deliver temporary Certificates that are printed, lithographed, typewritten, mimeographed or otherwise produced, in any authorized denomination, substantially of the tenor of the definitive Certificates in lieu of which they are issued and with such variations as the authorized officers executing such Certificates may determine, as evidenced by their execution of such Certificates. (b) If temporary Certificates are issued, the Depositor will cause definitive Certificates to be prepared without unreasonable delay. After the preparation of definitive Certificates, the temporary Certificates shall be exchangeable for definitive Certificates upon surrender of the temporary Certificates at the office or agency of the Trustee without charge to the Holder. Upon surrender for cancellation of any one or more temporary Certificates, the Trustee shall execute and authenticate and deliver in exchange therefor a like aggregate Certificate Principal Amount of definitive Certificates of the same Class in the authorized denominations. Until so exchanged, the temporary Certificates shall in all respects be entitled to the same benefits under this Agreement as definitive Certificates of the same Class.

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